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WO2008053593A1 - Système de purification du sang - Google Patents

Système de purification du sang Download PDF

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Publication number
WO2008053593A1
WO2008053593A1 PCT/JP2007/001186 JP2007001186W WO2008053593A1 WO 2008053593 A1 WO2008053593 A1 WO 2008053593A1 JP 2007001186 W JP2007001186 W JP 2007001186W WO 2008053593 A1 WO2008053593 A1 WO 2008053593A1
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WO
WIPO (PCT)
Prior art keywords
blood
circuit
blood circuit
true
hematocrit
Prior art date
Application number
PCT/JP2007/001186
Other languages
English (en)
Japanese (ja)
Inventor
Masahiro Toyoda
Tomoya Murakami
Original Assignee
Nikkiso Company Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nikkiso Company Limited filed Critical Nikkiso Company Limited
Publication of WO2008053593A1 publication Critical patent/WO2008053593A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A61M1/1613—Profiling or modelling of patient or predicted treatment evolution or outcome
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3607—Regulation parameters
    • A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3607—Regulation parameters
    • A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
    • A61M1/361—Physical characteristics of the blood, e.g. haematocrit, urea before treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3607—Regulation parameters
    • A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
    • A61M1/3612—Physical characteristics of the blood, e.g. haematocrit, urea after treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3656—Monitoring patency or flow at connection sites; Detecting disconnections
    • A61M1/3658—Indicating the amount of purified blood recirculating in the fistula or shunt
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • A61M2205/3313—Optical measuring means used specific wavelengths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/207—Blood composition characteristics hematocrit

Definitions

  • the present invention relates to a blood purification apparatus for purifying a patient's blood while circulating it extracorporeally.
  • a blood circuit comprising a flexible tube for circulating a patient's blood extracorporeally is used.
  • This blood circuit is mainly composed of an arterial blood circuit in which an arterial puncture needle for collecting blood from a patient is attached to the tip, and a venous blood circuit in which a venous puncture needle for returning blood to the patient is attached to the tip.
  • the dialyzer is interposed between the arterial blood circuit and the venous blood circuit to purify the blood circulating outside the body.
  • Such a dialyzer has a plurality of hollow fibers arranged therein, and blood passes through each of the hollow fibers, and the outside thereof (the outer peripheral surface of the hollow fiber and the inner peripheral surface of the housing). In the meantime, the dialysate can flow.
  • the hollow fiber has a blood purification membrane with micropores (pores) formed on its wall surface, and waste products of blood passing through the hollow fiber permeate the blood purification membrane and are discharged into the dialysate. At the same time, waste blood is discharged and purified blood is returned to the patient's body.
  • a water removal pump for removing water from the patient's blood is disposed so that water is removed during dialysis treatment.
  • the venous blood circuit is provided with a similar sensor to determine whether or not a specific peak is given to the change in blood concentration. Proposals have been made that can be confirmed and the parameters for determining the ratio of recirculated blood can be reduced to detect blood recirculation reliably and accurately (see, for example, Patent Document 2).
  • Patent Document 1 Special Table 2 0 0 0-5 0 2 9 4 0
  • Patent Document 2 Japanese Patent Laid-Open No. 2 0 0 6 _ 0 8 7 9 0 7
  • the conventional blood purification apparatus described above merely detects blood recirculation, so that it is still difficult to perform blood purification treatment considering the blood recirculation. there were.
  • the rate of change in circulating blood volume ( ⁇ ⁇ V) which is an index indicating the patient's condition
  • the clearance value which is an index indicating the amount and efficiency of dialysis by the dialyzer, etc. It is difficult for doctors and other healthcare professionals to predict in real time whether there is an impact, and it is impossible to perform ideal blood purification treatment considering the blood recirculation.
  • the present invention has been made in view of such circumstances, and provides a blood purification apparatus capable of performing an ideal blood purification treatment in consideration of blood recirculation. It is in.
  • the invention according to claim 1 is a blood circuit comprising an arterial blood circuit and a venous blood circuit for extracorporeally circulating the collected patient's blood, and a blood pump disposed in the arterial blood circuit.
  • a blood purification means connected between the arterial blood circuit and the venous blood circuit, for purifying blood flowing through the blood circuit, and for measuring a blood index indicating the concentration of blood circulating outside the blood circuit; Recirculation indicating the ratio of the flow rate of recirculated blood to the blood flowing through the arterial blood circuit of the recirculated blood that is led back to the arterial blood circuit from the venous blood circuit
  • a blood purification apparatus comprising a recirculation rate deriving unit capable of obtaining a rate, a true value deriving unit for obtaining a true blood index in a patient based on the recirculation rate obtained by the recirculation rate deriving unit Characterized by comprising.
  • the invention according to claim 2 is the blood purification apparatus according to claim 1, wherein the concentration measuring means is disposed in the blood circuit and measures a hematocrit value of blood flowing through the blood circuit.
  • a true blood index to be obtained by the true value deriving means is a hematocrit value.
  • the invention according to claim 3 is the blood purification apparatus according to claim 2, wherein the circulating blood is an index indicating the patient's condition based on the true hematocrit value obtained by the true value deriving means. It is characterized in that the rate of change in quantity is calculated.
  • the invention according to claim 4 is the blood purification device according to any one of claims 1 to 3, wherein the concentration measuring means includes an arterial blood circuit and a venous side in the blood circuit. It is arranged in each blood circuit.
  • the invention according to claim 5 is the blood purification apparatus according to claim 1, wherein the blood purification means comprises a dialyzer for introducing or deriving dialysate through a dialysis membrane, and the concentration measurement means comprises The blood index indicating the blood concentration can be measured from the dialysate pressure, which is the dialysate pressure derived from the dialyzer.
  • the invention according to claim 6 is the blood purification apparatus according to claim 1, wherein the concentration measuring means is disposed in the blood circuit and measures a hematocrit value of blood flowing through the blood circuit.
  • a solute concentration measuring sensor for measuring a solute concentration of blood flowing through the blood circuit, and a true blood index to be obtained by the true value deriving means is a solute concentration. .
  • the invention according to claim 7 is the blood purification apparatus according to claim 6, wherein the blood purification means comprises a dialyzer for introducing or deriving dialysate through a dialysis membrane, and the true value deriving means.
  • the blood purification means comprises a dialyzer for introducing or deriving dialysate through a dialysis membrane, and the true value deriving means.
  • a clearance value which is an index indicating the amount and efficiency of dialysis by the dialyzer, is calculated.
  • the true blood index to be obtained by the true value deriving means is the hematocrit value
  • the hematocrit value and various indices obtained from the hematocrit value are accurately determined. You can often ask.
  • the circulating blood volume change rate which is an index indicating the patient's condition, is calculated.
  • the rate of change in blood volume can be obtained in real time, and if used as an index during blood purification treatment, ideal blood purification treatment can be performed in consideration of blood recirculation.
  • the concentration measuring means is disposed in each of the arterial blood circuit and the venous blood circuit in the blood circuit, either the arterial blood circuit or the venous blood circuit is used. Compared to the case where only one of them has concentration measuring means, it is possible to reduce the parameters for determining the ratio of recirculated blood (recirculation rate) and to obtain the recirculation rate reliably and accurately. The true blood index can be obtained more quickly.
  • the concentration measuring means can measure the blood index indicating the blood concentration from the dialysate pressure that is the pressure of the dialysate derived from the dialyzer. There is no need to provide it on the circuit side.
  • the true blood index to be obtained by the true value deriving means is the solute concentration, it is possible to accurately obtain the solute concentration and various indicators obtained from the solute concentration. it can.
  • the clearance value which is an index indicating the amount and efficiency of dialysis by the dialyzer, is calculated based on the true solute concentration obtained by the true value deriving means.
  • the clearance value can be obtained in real time, and if used as an indicator during blood purification treatment, ideal blood purification treatment can be performed in consideration of blood recirculation.
  • the blood purification apparatus is for purifying a patient's blood while circulating it extracorporeally, and is applied to a dialysis apparatus used in dialysis treatment.
  • a dialyzer is mainly composed of a blood circuit 1 connected to a dialer 2 as a blood purification means, and a dialyzer body 6 for removing water while supplying dialysate to the dialyzer 2.
  • the blood circuit 1 is mainly composed of an arterial blood circuit 1 a and a venous blood circuit 1 b made of a flexible tube.
  • the arterial blood circuit 1 a and the venous blood Dialer 2 is connected between circuit 1 b.
  • An arterial puncture needle a is connected to the tip of the arterial blood circuit 1a, and an iron type blood pump 3 and a first hematocrit sensor 5a (concentration measuring means) ) Is provided.
  • a venous puncture needle b is connected to the distal end of the venous blood circuit 1b, and a second hematocrit sensor 5b (concentration measuring means) and a drip chamber 4 for defoaming are provided along the way. It is connected.
  • the first hematocrit set constituting the concentration measuring means in the present embodiment.
  • the sensor 5a and the second hematocrit sensor 5b are disposed in the arterial blood circuit 1a and the venous blood circuit 1b, respectively, and indicate the concentration of blood circulating outside the blood circuit 1.
  • Indicators (specifically, hematocrit values) can be measured in real time.
  • the hematocrit value is an index indicating the concentration of blood, and is specifically expressed by the volume ratio of erythrocytes in the whole blood.
  • the blood pump 3 When the blood pump 3 is driven in a state where the patient has punctured the arterial puncture needle a and the venous puncture needle b, the blood of the patient passes through the arterial blood circuit 1a and the dialyzer 2 Thus, blood purification is performed by the dialyzer 2, and the blood is returned to the patient's body through the venous blood circuit 1b while being defoamed in the dripping chamber 4. That is, the blood of the patient is purified by the dialyzer 2 while circulating outside the blood circuit 1.
  • the dialyzer 2 is formed with a blood introduction port 2a, a blood outlet port 2b, a dialysate inlet port 2c, and a dialysate outlet port 2d in the casing, and of these, the blood inlet port 2
  • the proximal end of the arterial blood circuit 1a is connected to a, and the proximal end of the venous blood circuit 1b is connected to the blood outlet port 2b.
  • the dialysate introduction port 2 c and the dialysate outlet port 2 d are connected to a dialysate introduction line L 1 and a dialysate discharge line L 2 extending from the dialyzer body 6, respectively.
  • a plurality of hollow fibers are accommodated in the dialyzer 2, the inside of the hollow fibers is used as a blood flow path, and dialysis is performed between the outer peripheral surface of the hollow fibers and the inner peripheral surface of the casing. It is a liquid flow path.
  • a hollow fiber membrane is formed in the hollow fiber by forming a number of minute holes (pores) penetrating the outer peripheral surface and the inner peripheral surface, and impurities in the blood and the like are passed through the membrane in the dialysate. It is comprised so that it can permeate
  • the dialysis machine body 6 includes a dual pump P formed over the dialysate introduction line L 1 and the dialysate discharge line L 2, and a dialysate discharge line L 2.
  • Mainly comprising a bypass line L 3 bypassing the duplex pump P and a dewatering pump 8 connected to the bypass line L 3.
  • One end of the dialysate introduction line L 1 is connected to a dialyzer 2 (dialyte introduction port 2 c), and the other end is connected to a dialysate supply device 7 for preparing a dialysate having a predetermined concentration.
  • dialysate discharge line L2 is connected to the dialyzer 2 (dialysate outlet port 2d), and the other end is connected to a drainage means (not shown).
  • a drainage means not shown.
  • the dialysate supplied from the device 7 reaches the dialyzer 2 through the dialysate introduction line L 1, it is sent to the drainage means through the dialysate discharge line L 2 and the bypass line L 3. Yes.
  • reference numerals 9 and 10 indicate a heater and deaeration means connected to the dialysate introduction line L 1.
  • the water removal pump 8 is for removing water from the blood of the patient flowing in the dialyzer 2. That is, when the dewatering pump 8 is driven, since the double pump P is a fixed type, the amount of liquid discharged from the dialysate discharge line L 2 is larger than the amount of dialysate introduced from the dialysate introduction line L 1. The volume of water increases, and water is removed from the blood by that much volume. The water may be removed from the patient's blood by means other than the water removal pump 8 (for example, using a so-called balancing chamber).
  • the water removal pump 8 of the present embodiment can perform water removal abruptly and in a short time in addition to water removal necessary for dialysis treatment. That is, water removal at a constant rate performed during dialysis treatment is temporarily stopped (extracorporeal circulation is performed), and when the measured hematocrit value is stabilized, the water removal pump 8 is driven rapidly and for a short time. By dehydrating the water, it is possible to give a peculiar peak to the change in blood concentration (hematocrit value) during that time.
  • “rapid and short time” in the present invention means a size and time that can be confirmed after passing through a circuit
  • “specific” means pump fluctuations and patient's body. It can be distinguished from fluctuation patterns due to other factors caused by movement.
  • the first hematocrit sensor 5a and the second hematocrit sensor 5b are disposed in the arterial blood circuit 1a and the venous blood circuit 1b, respectively. It detects the concentration of blood flowing through the circuit (specifically, hematocrit value). For example, it has a light emitting element such as an LED and a light receiving element such as a photodiode, and irradiates the blood with light from the light emitting element. The hematocrit value indicating the blood concentration of the patient is detected by receiving the transmitted or reflected light with a light receiving element.
  • a hematocrit value indicating the blood concentration is obtained based on the electrical signal output from the light receiving element. That is, each component of blood such as red blood cells and plasma has its own light absorption characteristics. Using this property, the red blood cells required for measuring hematocrit are quantified electro-optically. By doing so, the hematocrit value can be obtained. More specifically, near infrared light irradiated from the light emitting element is incident on blood, is affected by absorption and confusion, and is received by the light receiving element. From the intensity of the received light, the light absorption / scattering rate is analyzed, and the hematocrit value is calculated.
  • the first hematocrit sensor 5a configured as described above has an arterial blood circuit.
  • the first hematocrit sensor 5a is used to detect the hematocrit value of blood collected from the patient via the arterial puncture needle a during dialysis treatment, and the second hematocrit sensor 5b Since it is arranged in the circuit 1b, the hematocrit value of the blood purified by the dialer 2 and returned to the patient is detected. That is, the peculiar peak given by the water removal pump 8 is first detected by the second hematocrit sensor 5 b (see FIG. 4), and then the blood reaches the arterial blood circuit 1 a again and recirculates. In the recirculated blood. The unique peak can be detected by the first hematocrit sensor 5a (see Fig. 5).
  • the first hematocrit sensor 5a and the second hematocrit sensor 5b are electrically connected to the arithmetic means 1 1 disposed in the dialyzer body 6 as shown in FIG.
  • the computing means 11 is electrically connected to a display means 14 such as a liquid crystal screen via a true value deriving means 12 and a circulating blood volume change rate calculating means 13.
  • the computing means 11 is composed of, for example, a microcomputer and compares the hematocrit values (specific peaks) detected by the first hematocrit sensor 5a and the second hematocrit sensor 5b.
  • Percentage of recirculated blood in the blood flowing through the arterial blood circuit 1a (that is, recirculated blood flowing from the venous blood circuit 1b to the patient again through the arterial blood circuit 1a)
  • the ratio of the flow rate to the blood flowing through the arterial blood circuit 1a which is hereinafter referred to as the recirculation rate.
  • the computing means 11 recognizes that the hematocrit value detected by the first hematocrit sensor 5a and the second hematocrit sensor 5b exceeds a predetermined value. The hematocrit values exceeding the numerical value may be compared with each other.
  • the change in the hematocrit value of the first hematocrit sensor 5a and the second hematocrit sensor 5b is obtained.
  • the area of the time part (change part) to be compared as described above is calculated by a mathematical method such as an integration method.
  • the area of the change due to the second hematocrit sensor 5b (the part from t5 to t6 in Fig. 4) is Sv
  • the change due to the first hematocrit sensor 5a (t in Fig. 5)
  • the recirculation rate AR can be calculated by the following equation.
  • a R (%) S a / S v X l O O
  • the time of the change portion by the first hematocrit sensor 5a (time interval from t7 force, etc. to t8) is that the blood to which a specific peak is applied is the second hematocrit sensor 5b.
  • it is set to be larger than the time of change by the second tomatocrit sensor 5b (time interval from t5 to t6). Yes.
  • the water removal pump 8 and the calculation means 1 1 that can give a specific peak constitute the recirculation rate deriving means in the present embodiment, so that the recirculation rate can be obtained by them. It is summer.
  • the recirculation rate obtained by the computing means 1 1 is sent to the true value deriving means 1 2 constituted by a microcomputer or the like, for example, so that the true hematocrit value (blood index) in the patient is obtained. .
  • the first hematocrit sensor 5a measures the hematocrit value of blood that has not been purified by the dialyzer 2, so that there is no blood recirculation.
  • the measurement value of the first hematocrit sensor 5a should be the hematocrit value of the patient, but if there is blood recirculation, the measurement value of the first hematocrit sensor 5a is not necessarily the patient. In consideration of the fact that it does not match the true hematocrit value, the true hematocrit value can be obtained by the true value deriving means 12.
  • the flow rate (shunt flow rate) of a shunt (such as a short circuit portion of a blood vessel on the human body side) is Q a
  • the blood flowing through the blood circuit 1 by the action of the blood pump 3 The flow rate (blood pump flow rate) is Q b
  • the recirculation blood flow rate (recirculation flow rate) is Q r
  • the hematocrit value measured by the first hematocrit sensor 5 a is H t 1 and the second hematoma.
  • H ta (H t 1 -H t 2 x AR) / (1 -AR) (Equation 3) That is, H t 1 which is the measured value of the first hematocrit sensor 5 a, second hematocrit sensor Since the measured value H t 2 of 5b and the AR obtained by the computing means 11 are known parameters, the true hematocrit value H ta can be obtained from the above equation 3.
  • the true blood index (hematocrit) in the patient is calculated by the true value deriving means 12 based on the recirculation rate obtained by the computing means 1 1 (recirculation rate deriving means). Value), it is possible to perform ideal blood purification treatment considering blood recirculation. Further, since the true blood index to be obtained by the true value deriving means 12 is a hematocrit value, the hematocrit value and various indices obtained from the hematocrit value can be obtained with high accuracy.
  • the true hematocrit value obtained as described above is sent to the circulating blood volume change rate calculating means 13 constituted by, for example, a microcomputer or the like, and based on the true hematocrit value, the patient
  • the rate of change in circulating blood volume (ABV) which is an index indicating the state of the disease, can be calculated. This rate of change in circulating blood volume (ABV)
  • the circulating blood volume change rate calculating means 13 uses the circulating blood volume change rate ( ⁇ BV ) Is calculated, it is possible to obtain an accurate rate of change in circulating blood volume (ABV) in real time, and if it is used as an indicator during blood purification treatment, an ideal blood purification treatment considering blood recirculation can be performed. Can be made.
  • the circulating blood volume change rate (ABV) calculated by the circulating blood volume change rate calculating means 13 is displayed on the display means 14 in real time.
  • the first hematocrit sensor 5a and the second hematocrit sensor 5b as concentration measuring means include the arterial blood circuit 1a and the venous blood circuit in the blood circuit 1. 1 b, since it is arranged in each of the arterial blood circuit 1a and the venous blood circuit 1b, a hematocrit sensor as a concentration measuring means is arranged only in one of them. Find recirculation rate The recirculation rate can be determined reliably and accurately by reducing the number of parameters, and the true blood index can be determined more quickly.
  • the first hematocrit sensor 5a and the second hematocrit sensor 5b as the concentration measuring means are used as the arterial blood circuit 1a and the venous blood circuit 1 respectively.
  • it may be provided only in the arterial blood circuit 1b.
  • the true hematocrit value H t a can be obtained by the following equation.
  • H t a ⁇ H t 1-(H t 1 x A R x Q b) / (Q b _ Q u f) ⁇ / (1-A R)
  • the first hematocrit sensor 5a and the second hematocrit sensor 5b as the concentration measuring means are disposed on the blood circuit 1 side.
  • the concentration measuring means may measure a blood index (hematocrit value, hemoglobin concentration, etc.) indicating the blood concentration from the dialysate pressure that is the pressure of the permeate derived from the dialyzer 2.
  • this blood purification device is for purifying a patient's blood while circulating it extracorporeally.
  • Blood circuit 1 to which dialyzer 2 as a blood purification means is connected is connected to dialyzer 2 Mainly composed of a dialysis machine body 6 that removes water while supplying water, and is applied to a dialysis machine used in dialysis treatment.
  • the same components as those in the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.
  • the arterial blood circuit 1 a and the venous blood circuit 1 b in the present embodiment have a hematocrit sensor 5 for measuring the hematocrit value of blood flowing through these blood circuits.
  • a first solute concentration measuring sensor 15a and a second solute concentration measuring sensor 15b are provided.
  • the first solute concentration measurement sensor 15a and the second solute concentration measurement sensor 15b measure the solute concentration (urea concentration, etc.) of blood flowing through the arterial blood circuit 1a and venous blood circuit 1b, respectively. To do.
  • the first solute concentration measuring sensor 15 5 a and the second solute concentration measuring sensor 15 b are electrically connected to the calculating means 1 1 ′, and the calculating means 1 1 ′ is electrically connected to the clearance value calculation means 1 6 through the true value derivation means 1 2 ′.
  • the calculation means 1 1 ′ constitutes a recirculation rate deriving means together with the water removal pump 8 that can give a specific peak, and the recirculation rate (AR) can be obtained by these means. It has become.
  • the method for deriving the recirculation rate (A R) is the same as in the previous embodiment.
  • the recirculation rate obtained by the computing means 1 1 ' is sent to the true value deriving means 1 2' constituted by, for example, a microcomputer so that the true solute concentration (blood index) in the patient is obtained. It is configured. Specifically, as shown in FIG.
  • the flow rate (shunt flow rate) of the shunt (such as a short circuit portion of the blood vessel on the human body side) is Q a
  • the flow rate of blood flowing through the blood circuit 1 by the action of the blood pump 3 (blood pump Flow rate) is Qb
  • recirculated blood flow rate (recirculation flow rate) is Qr
  • the solute concentration measured by the first solute concentration measurement sensor 15a is Cin
  • the second solute concentration measurement sensor 15b is
  • Equation 5 The equation for obtaining the true solute concentration C a from Equation 5 is as follows.
  • Equation 6 (C in + C outx AR) / (1 -AR) (Equation 6) That is, C in, which is the measured value of the first solute concentration sensor 15 a, and the second solute concentration sensor 15 b Since the measured value C out and the AR obtained by the computing means 1 1 ′ are known parameters, the true solute concentration C a can be obtained from Equation 6 above.
  • the true value deriving means 1 2 ' is based on the recirculation rate obtained by the computing means 1 1' (recirculation rate deriving means). Since a true blood index (solute concentration) in a patient can be obtained, an ideal blood purification treatment considering blood recirculation can be performed. In addition, since the true blood index to be obtained in the true value deriving means 12 'is the solute concentration, the solute concentration and various indices obtained from the solute concentration can be obtained with high accuracy.
  • the true solute concentration obtained as described above is sent to a clearance value calculating means 16 constituted by, for example, a microcomputer, and the amount of dialysis by the dialyzer 2 is based on the true solute concentration.
  • a clearance value K which is an index indicating efficiency, can be calculated.
  • This clearance value K is a parameter mainly indicating the substance removal performance of the dialyzer 2, and indicates how many milliliters of blood per minute that has passed through the dialyzer 2 has been purified.
  • the clearance value depends on the membrane area of the dialyzer used, the blood flow rate (blood volume circulating extracorporeally), the properties of the membrane, and the like. This parameter should be grasped in advance.
  • the clearance value K in the absence of water removal is generalized by a mathematical formula, it is as follows.
  • Equation 7 when there is no recirculated blood, C in (solute concentration measured by the first solute concentration measuring sensor 15 a) and C a (true solute concentration) are equal force recirculation When blood is generated, C in and Ca are not equal, and an error occurs in the clearance value obtained by the above general formula. Therefore, in this embodiment, based on the true solute concentration obtained by the true value deriving means 1 2 ′, the clearance value which is an index indicating the amount and efficiency of dialysis by the dialyzer 2 in the clearance value calculating means 1 67 It is configured to calculate KO (true clearance value).
  • C a / C in can be considered as a correction factor for determining the true clearance value KO.
  • the correction coefficient for determining the true clearance value K0 can be obtained by the above equation 9
  • the true clearance value K0 can be obtained by multiplying the inherent clearance value K of the dialyzer 2 by the correction coefficient. Can be sought. Therefore, the clearance value can be obtained with high accuracy in real time, and if used as an index during blood purification treatment, ideal blood purification treatment can be performed in consideration of blood recirculation.
  • the first solute concentration measuring sensor 15 a and the second solute concentration measuring sensor 15 b as the concentration measuring means are connected to the arterial blood circuit 1 a and the venous side.
  • each of the blood circuits 1b is disposed, it may be disposed only in the arterial blood circuit 1b instead.
  • the true solute concentration C a can be obtained as follows. [0071] The following equation is obtained from the definition equation of the clearance value K.
  • the recirculation rate deriving means has another form (for example, physiological saline or the like as a venous blood circuit).
  • a unique peak may be given by injection, and the recirculation rate may be derived by detecting the peak with an arterial blood circuit).
  • the true blood index to be obtained is a hematocrit value or a solute concentration.
  • other blood indices for example, hemoglobin concentration, protein concentration, etc.
  • the true blood index in may be obtained.
  • the parameter calculated from the true blood index may be another parameter instead of the circulating blood volume change rate (ABV) or the clearance value as in the above embodiment.
  • PW I plasma water index
  • true blood index is an index of how much the change in body weight (decrease) due to water removal affects the blood concentration. be able to.
  • PW I indicates that the blood concentration rate for weight loss due to water removal is large, and interstitial fluid is replenished from outside the blood vessel while water is deprived of water by water removal. While PW I is small, blood It can be recognized that there is room for replenishment of interstitial fluid even if moisture is taken from the fluid.
  • an index Kt / V can be used as another index indicating the dialysis efficiency to be calculated based on the true blood index (solute concentration).
  • This index can be obtained by the following formula. Where K is the clearance value, t is the time, and V is the distribution volume.
  • the water removal pump is applied as a blood concentration means for giving a peak peculiar to a change in blood concentration by performing water removal rapidly and for a short time. Others may be used as long as they can concentrate blood other than the pump. Furthermore, an alarm may be sounded when the percentage of recirculated blood exceeds a predetermined value to alert the medical staff.
  • the dialysis device body 6 is composed of a dialysis monitoring device that does not incorporate a dialysate supply mechanism, but may be applied to a personal dialysis device that incorporates a dialysate supply mechanism. .
  • a blood purification apparatus provided with a true value deriving unit for obtaining a true blood index in a patient based on the recirculation rate obtained by the recirculation rate deriving unit can purify blood while allowing extracorporeal circulation. It can also be applied to those used in other treatments (blood filtration therapy, hemodiafiltration, plasma exchange therapy, etc.) or with other functions added.
  • FIG. 1 is an overall schematic diagram showing a blood purification apparatus according to a first embodiment of the present invention.
  • FIG. 2 is a schematic diagram showing the main body of a dialysis machine in the blood purification apparatus.
  • FIG. 3 is a graph showing control of a water removal pump in the blood purification apparatus, and shows that water removal is performed rapidly and in a short time.
  • FIG. 4 is a graph showing changes in the hematocrit value detected by the second hematocrit sensor in the blood purification apparatus.
  • FIG. 5 A graph showing changes in the hematocrit value detected by the first hematocrit sensor (when there is recirculation) in the blood purification apparatus.
  • FIG. 6 is a block diagram showing the connection relationship of the first hematocrit sensor, the second hematocrit sensor, the computing means, the true value deriving means, the circulating blood volume change rate calculating means, and the display means in the blood purification apparatus.
  • FIG. 7 is an explanatory diagram schematically showing the case where recirculated blood is generated in the blood purification apparatus.
  • FIG. 8 is an explanatory view schematically showing a case where recirculation occurs in the blood purification apparatus according to the second embodiment of the present invention.
  • FIG. 9 is a block diagram showing the connection relationship of the first solute concentration measurement sensor, the second solute concentration measurement sensor, the calculation means, the true value derivation means, and the clearance value calculation means in the blood purification apparatus.
  • Dializer blood purification means

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
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Abstract

L'invention a pour objet un système de purification du sang qui permet d'effectuer une thérapie de purification du sang idéale tout en prévoyant une recirculation du sang. L'invention concerne un système de purification du sang comprenant un circuit de sang (1) constitué d'un circuit de sang du côté artériel (1a) et d'un circuit de sang du côté veineux (1b), une pompe pour le sang (3) disposée dans le circuit de sang du côté artériel (1a), un dialyseur (2) servant à purifier le sang coulant dans le circuit de sang (1), des capteurs d'hématocrites (5a, 5b) servant à mesurer le taux d'hématocrites du sang en circulation extracorporelle dans le circuit de sang (1) et des moyens servant à déterminer le taux de recirculation par lesquels on peut obtenir le taux de recirculation, caractérisé en ce qu'il est pourvu de moyens de détermination du taux réel (12) grâce auxquels on détermine le taux réel d'hématocrites d'un patient sur la base du taux de recirculation déterminé par les moyens de détermination du taux de recirculation.
PCT/JP2007/001186 2006-11-01 2007-10-30 Système de purification du sang WO2008053593A1 (fr)

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DE102008003714A1 (de) * 2008-01-09 2009-07-16 Fresenius Medical Care Deutschland Gmbh Verfahren zum Bestimmen des Anteils der Rezirkulation in einer Fistel und/oder der kardiopulmonalen Rezirkulation an der Summe von Fistelrezirkulation und kardiopulmonaler Rezirkulation
JP2010068927A (ja) * 2008-09-17 2010-04-02 Nikkiso Co Ltd 血液浄化装置
CN102008763B (zh) * 2010-12-08 2012-10-24 重庆山外山科技有限公司 血液净化用自动配液系统及其使用方法
JP5736268B2 (ja) * 2011-07-27 2015-06-17 日機装株式会社 血液浄化装置
JP6998112B2 (ja) * 2016-09-12 2022-01-18 日機装株式会社 血液浄化装置
US10625011B2 (en) * 2017-09-29 2020-04-21 Fresnius Medical Care Holdings, Inc. System and method for dialyzer evaluation
JP7061509B2 (ja) 2018-04-26 2022-04-28 日機装株式会社 血液浄化装置
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